Trial Outcomes & Findings for Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy (NCT NCT01819233)
NCT ID: NCT01819233
Last Updated: 2025-06-06
Results Overview
Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Up to week 12
Results posted on
2025-06-06
Participant Flow
Participant milestones
| Measure |
Behavioral Dietary Intervention
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy
Baseline characteristics by cohort
| Measure |
Behavioral Dietary Intervention
n=38 Participants
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to week 12Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.
Outcome measures
| Measure |
Behavioral Dietary Intervention
n=32 Participants
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Number of Participants Who Are Adherent to the Diet Restriction
|
28 participants
Interval to 74.5
one sided lower confidence limit as one-sided alpha used.
|
SECONDARY outcome
Timeframe: Baseline to 4 weeks after completion of studyPopulation: patients who did not complete all assessments were not included in the analysis
Analyzed via a paired t-test. Change in body fat measurement as determined by the Durnin-Womersley 4-fold technique
Outcome measures
| Measure |
Behavioral Dietary Intervention
n=29 Participants
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Change in Body Fat Measurement
|
-3.1 percentage of change in body fat
Interval -4.7 to -1.5
|
SECONDARY outcome
Timeframe: Baseline to 4 weeks after completion of studyPopulation: participants who did not complete all timepoint measurements were not included.
Assessed via mixed-effects regression. Weight changes over time assessed by modeling BMI as a function of time
Outcome measures
| Measure |
Behavioral Dietary Intervention
n=31 Participants
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Change in Body Mass Index (BMI)
|
-1.2 percentage of change in BMI
Interval -1.6 to -0.8
|
SECONDARY outcome
Timeframe: Baseline to 4 weeks after completion of studyPopulation: only participants who completed all timepoints were included
Assessed via mixed-effects regression.
Outcome measures
| Measure |
Behavioral Dietary Intervention
n=32 Participants
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Change in Heart Rate Over Time
|
67.3 beats per minute
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline to 4 weeks after completion of studyAssessed via mixed-effects regression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 4 weeks after completion of studyPopulation: patients who did not complete all questionnaire timepoints were not included in the analysis
Assessed via mixed-effects regression. The FACT-B is a questionnaire using a 5-point Likert scale (0-Not at all to 4-Very much)
Outcome measures
| Measure |
Behavioral Dietary Intervention
n=31 Participants
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)
|
0.8 score on a scale
Interval -6.2 to 7.8
|
SECONDARY outcome
Timeframe: Up to 4 weeks after completion of studyAnalyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Outcome measures
| Measure |
Behavioral Dietary Intervention
n=38 Participants
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Local Recurrence
|
NA Participants
Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.
|
SECONDARY outcome
Timeframe: Up to 4 weeks after completion of studyAnalyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Outcome measures
| Measure |
Behavioral Dietary Intervention
n=38 Participants
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Distant Metastases
|
NA Participants
Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.
|
SECONDARY outcome
Timeframe: Up to 4 weeks after completion of studyAnalyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Outcome measures
| Measure |
Behavioral Dietary Intervention
n=38 Participants
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Progression Free Survival
|
NA Participants
Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.
|
SECONDARY outcome
Timeframe: Up to 4 weeks after completion of studyPopulation: Insufficient data was collected to conduct survival analysis as there were participants who were lost to follow up.
Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Outcome measures
| Measure |
Behavioral Dietary Intervention
n=38 Participants
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Overall Survival
|
NA Participants
Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.
|
Adverse Events
Behavioral Dietary Intervention
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Behavioral Dietary Intervention
n=38 participants at risk
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
34.2%
13/38 • Number of events 38 • baseline through 5 weeks after completion of study diet.
|
|
General disorders
fatigue
|
34.2%
13/38 • Number of events 38 • baseline through 5 weeks after completion of study diet.
|
|
General disorders
hot flashes
|
13.2%
5/38 • baseline through 5 weeks after completion of study diet.
|
|
Skin and subcutaneous tissue disorders
hyperpigmentation
|
26.3%
10/38 • baseline through 5 weeks after completion of study diet.
|
Additional Information
Dr. Nicole Simone
Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-955-6702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place